Legend Biotech
IT Validation Specialist
$68K–$89K
Somerset, New Jersey, United States · Full-time · Posted Aug 27, 2026
- Experience
- 1-3 years of hands-on CSV experience in biotech or pharmaceutical industries.
- Education
- Bachelor’s Degree in a Life Science, IT, Engineering or a related field
- Visa sponsorship
- Applicants must be authorized to work in the United States.
About the job
Supports validation of GxP-regulated computerized systems, ensuring compliant implementation, operation, and maintenance throughout their lifecycle.
What you'll do
- Execute CSV/CSA activities, author validation documents, and perform risk-based assessments.
- Coordinate validation testing, document results, and resolve testing issues and deviations.
- Maintain validated status through change controls, periodic reviews, audit support, and guidance to system owners.
What they ask for
- Bachelor’s Degree in a Life Science, IT, Engineering or a related field
- 1-3 years of hands-on experience in Computer System Validation (CSV) within the biotech or pharmaceutical industries
- Experience using an automated Validation Lifecycle Management System (VLMS) and executing validation projects and deliverables
- Knowledge of GxP regulations and risk-based CSV/CSA methodologies
Nice to have
- Experience with Computer Software Assurance (CSA) and AI
- Experience with ValGenesis and Veeva Quality Vault
Pay
$68,045 — $89,308 USD (base pay)
Tools
VLMS, EDMS, QMS, ValGenesis, Veeva Quality Vault, FDA 21 CFR Part 11, EU Annex 11, GAMP 5
AI focus
AI literacy and responsible use of approved AI tools; AI validation and use of AI in GxP validation activities are a plus.
Model-written summary · the original posting is authoritative